Intravascular devices, such as guide wires, catheters, guide catheters, etc., can be configured for imaging, flow measurement, and/or pressure measurement, among other functions. Such intravascular devices are generally disposable devices. Further, a manufacturer generally rates the intravascular device for a single use. That is, the manufacturer guarantees the safety of the intravascular device and/or the integrity of the data collected using the intravascular device for a single use. After being used within the vasculature of a patient in a clinical procedure, the intravascular device is discarded.
Recently, third parties that are not authorized by the manufacturer have collected used intravascular devices. The used intravascular devices are then sterilized, repackaged, and sold for future use in clinical procedures. This presents significant risk to patients. These intravascular devices have not been verified and validated, and therefore cannot be guaranteed or expected to meet the necessary safety and efficacy standards of an authentic intravascular device. When an intravascular device is inappropriately reused, it can expose patients to direct harm via contamination. It can also expose patients to the possibility of misdiagnosis when a disposable intravascular device is used for a longer time than it was designed to operate safely. In addition to patient safety concerns, a manufacturer also suffers financial losses when customers purchase repackaged, used intravascular devices as opposed to authorized ones.
Some efforts have been made previously to ensure that only authorized intravascular devices are used in clinical procedures. These efforts include preventing the use of intravascular devices whose on-board data did not pass some check conducted by a computing device in the clinical environment. However, third parties have been able to falsify the on-board data so that the computing device treats the intravascular device as authentic.
Further, while a third party without detailed knowledge of the intravascular device is unsuited to reprocess or recondition a used intravascular device, a manufacturer or authorized party is well suited to do so.
Thus, there remains a need for an authentication system that comprehensively prevents the use of unauthorized, fraudulent, and/or otherwise tampered-with intravascular devices. When a manufacturer or an authorized party reconditions a used intravascular device, the authentication system also needs to permit the device to be used in a clinical procedure.